Blood plasma and vaccine maker
CSL
intends to release three new products and will have almost 500 patients enrolled across six late stage clinical­trials during 2014, chief scientific officer
Andrew Cuthbertson
says.

At the company’s research and development briefing, where a tie-up with United States company
Janssen Biotech
was announced, Dr Cuthbertson said despite some “slippage" of timelines in the development of one product, the past 12 months had been successful. CSL released seven ­products in 2013. The company expects R&D ­expenditure to rise 13 per cent to $US480 million ($531 million) in 2013-14. CSL has more than 1000 scientists across five ­countries.

Dr Cuthbertson said the most ­challenging part of his job is balancing the costs and resources for late stage ­trials and regulatory applications, against early stage R&D. “If we don’t keep investing in early stage opportunities, the well will run dry," he said.

Highlighting the delicate balance, the company announced a partnership with
Johnson & Johnson
subsidiary, Janssen, to take on clinical research of its novel cancer therapy CSL362. The product is an antibody that recognises molecules on the surface of cancer cells. It binds to the cancer cells, acting as a flag for the natural immune response.

CSL is conducting a phase-1 trial, looking at the treatment of acute ­myeloid leukaemia. If the early stage trial is successful Janssen will take over future development and commercialisation. CSL will receive a licence fee and royalty on sales. It is hoped CSL362 could also treat auto-immune diseases.

Dr Cuthbertson said in therapeutic areas like immunoglobulins and ­coagulation factors, CSL has the ability to take product development further. But the company could not “do justice" to this project, he said. “Specialist oncology is not something we’re good at," Dr Cuthbertson said. “We know that for Janssen and Johnson & Johnson, this is an area that they concentrate on. They’re big and strong and capable."

UBS analyst Andrew Goodsall said he expected the release of Kcentra for expanded use in the US to have the biggest impact of the three CSL products to be launched in 2014. Kcentra controls major bleeding in patients, using blood thinning agents such as warfarin. This use was approved by regulators in April 2013 and Mr Goodsall said it had done “extraordinarily well".

CSL is seeking further approval to use Kcentra in patients requiring surgery. As in this example, much of CSL’s R&D is tied to developing new uses for existing products, as well as seeking regulatory approval for those products into new countries.

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Dr Cuthbertson blamed clinical trial delays for CSL’s recombinant factor 9 protein on the competitive market from which to recruit patients and the time taken to ensure clinical trial sites were compliant with quality standards.

CSL shares closed down 0.8 per cent to $67.79 on Thursday, down from 12-month high of $69.50 in October.